Too many companies fail to be compliant with GMPs and AERs, the FDA warns

"Inflammation if a harbinger of dysfunction, that's our view," the FDA states. "You can't have healthy dysfunction. If you say 'flavanoid supports a healthy immune response following exercise' —that's a tough claim to claim.

Daniel Fabricant, head kahuna at the Food and Drug Administration, spends a fair number of days each year traveling to trade shows and giving attendees the skinny: What is the FDA up to now? What type of regulatory actions are we likely to see coming down the pike?

This spring, one of his answers sparked a flurry of controversy that folks talked about for days.

First, though, here is some background:

In his opening remarks, Fabricant reported that there continues to be widespread noncompliance in the industry. "We are still seeing systemic noncompliance with dietary supplements for GMPs and AERs," he said. "There are companies that don't know how to send specifications for testing; others who are not qualifying their suppliers; multicomponent vitamins can be confusing to test —there are ways to reduce what you have to test, but people don't know that.

"We also see a lot of spiking with APIs in sex-enhancement products," Fabricant said. "These people need to be chased out of our business space. They're in the fraud business. Legitimate businesses need to make sure they are not in business with these people."

At this point, an unidentified person in the audience came forward to the mic with a question: "It seems that five or six years ago, it was okay to say on a package 'supports a healthy inflammatory response,' " she said. "But we are getting the message now that this is no longer OK. Is that true?"

Fabricant shook his head in agreement.

"Inflammation if a harbinger of dysfunction, that's our view," he said. "You can't have healthy dysfunction. If you say 'flavanoid supports a healthy immune response following exercise' —that's a tough claim to claim.

It is?

What if your ingredient really does help keep a lid on inflammation. How else are product manufacturers able to communicate this to consumers?

Inflammation all Comes Down to Balance

David K Barker, CEO of ALP, was not at the talk, but he offered an immediate reaction to Fabricant's remarks.

"You are addressing a critical subject that is often misunderstood. The FDA's concern with 'healthy inflammation' statements is very legitimate. The science regarding the pro-inflammatory and anti-inflammatory forces at work in the human body is often misunderstood by consumers. Labels making 'healthy inflammation' statements can be confusing.  

"Inflammation is in fact a disease state.

"Many people do not realize that inflammation plays a lead but typically silent role in most chronic diseases. The key is that physicians and patients need to pursue a balance between the pro-inflammatory and anti-inflammatory forces at work in the diet.

This discussion points directly to the emerging science and need for wider use of various omega 6 vs. omega 3 balance and blood testing by physicians and patients. The Omega Score is one such test. The average person is way out of balance in terms of omega 6 vs. omega 3 balances, which is the key to balancing pro-inflammatory vs. anti-inflammatory forces. The imbalance is typically toward a combination of too many omega 6s with too few omega 3s. "This makes most individuals vulnerable to far too much pro-inflammatory activity, producing excessive inflammation and chronic diseases," Barker said.

"It would be very difficult to fit clear statements on a label that can clarify the pro-inflammatory vs. anti-inflammatory story for consumers."

ALP Creates Video to Explain Body's Inflammatory Forces

ALP solution's has been to create “10 minute Urgent Medical Message” presentation from Dr. Robert Barker for the purpose of addressing the specific issue of the pro-inflammatory vs. anti-inflammatory forces in the diet. The objective was to educate both physicians and patients. The company tried to get the message into 4 minutes — but alas, it took 10. To view the presentation, click here:

ALP Life Sciences LLC is most recently in the news for a launching its ALP High 3 Omega 3 fish oil supplement in triglyceride form, with 1200 mg of EPA and DHA in a daily serving of two soft gels. ALP High 3 is formulated to provide the greatest possible absorption and bioavailability among omega-3 preparations.

ALP High 3 is the natural triglyceride form, not an ethyl ester form.

Most fish oil currently available is in the ethyl ester form, which can reduce absorption by more than 50%, and must be converted to the natural triglyceride form by our bodies prior to absorption. ALP High 3 is also enteric coated, increasing absorption by 60% or more over non-enteric coated products.

ALP High 3 can deliver greater than 10 times more omega 3 absorption than other formulations, making ALP High 3 the leading choice for improving health and wellness with anti-inflammatory omega 3s.     

Physicians can register with ALP to participate in the ALP High 3 sample program. They can refer patients to to their local pharmacy, or offer ALP High 3 in their practice.


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